How to perform GMP-compliant mapping studies efficiently

A mapping study has established the temperature distribution within the zone being mapped and identifies any hot or cold spots. The data collected provides an essential source of information to ensure product quality and patient safety. Mapping is typically performed for freezer rooms, cold rooms, temperature-controlled storage areas, quarantine areas, receiving and loading bays and laboratories.

SenseAnywhere offers real time thermal mapping tools. The wireless data loggers are accurate and reliable with minimal long-term drift, allowing increased confidence in your studies. The automated data processing makes mapping efficient and easy, whilst eliminating human-errors. SenseAnywhere’s real time temperature mapping tools enable you to demonstrate the temperature profile throughout your storage area. The report will also highlight any areas of concern which may require remedial action before being used for the storage of temperature-sensitive products.

Real time data monitoring
When a SenseAnywhere AccessPoint is deployed during the mapping exercise, data becomes real time available to view in our online application. This makes it simple to check that all sensors are operational and fully functioning, reducing the prospect of having to repeat the mapping exercise.

FDA 21 CFR Part 11 compliance
SenseAnywhere guarantees that the data collected from a mapping exercise, either real time or stored data, is genuine. There is no human manipulation in the process from data collection to cloud storage and data processing. By autonomously performing all calculations and charting of the data, errors belong to the past.

Furthermore, the software does not allow any adding, changing or deletion of data. Regulatory authorities and auditors can easily verify if the digital mapping report you have provided is genuine. The online tool checks if the report has been altered after generation, in line with FDA 21 Part 11 requirements regarding electronic data records.

Mapping partners
Although SenseAnywhere’s products and tools make the actual mapping exercise effortless, experts with mapping experience are essential in making critical process decisions. They determine the quantity and location of the monitoring devices, review the numeric data, draw conclusions and compose recommendations. SenseAnywhere is working with mapping partners that have the expertise to provide you with a complete solution of mapping services that meets your requirements.

SenseAnywhere’s thermal mapping highlights

• Small and robust wireless data loggers with NIST-traceable or ISO 17025:2005 calibration certificates
• Easy to place and use without any pre-setup or wiring involved and no buttons to press
• High accuracy: ±0.10°C (0 to 70°C) and ±0.15°C (-40 to 0°C) and long term stability (drift over time <0.01°C/year)
• Easy to use online application, no installation required, with detailed and customisable reports
• All data real time available in the Cloud database where it is stored securely for at least five years
• Fully automatic report generation; no human intervention and genuine data is guaranteed
• Tabular and graphical reports that are in line with 21 CFR Part 11
• Simple and efficient mapping process with a minimum of time and resources